SAT0253 Dose reduction of baricitinib in patients with rheumatoid arthritis achieving sustained disease control: results of a prospective study
Authors: T. Takeuchi, M. C. Genovese, B. Haraoui, Z. Li, L. Xie, R. Klar, A. P. Correia, S. Otawa, P. Lopez-Romero, I. De La Torre, T. Rooney, J. S. Smolen
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background:</h3> In patients with rheumatoid arthritis (RA) and inadequate response (IR) to DMARDs, ph3 studies demonstrated efficacy of baricitinib (Bari) (2-mg and 4-mg). <h3>Objectives:</h3> To investigate the effects of Bari dose step-down in patients who achieved sustained disease control with Bari 4-mg. <h3>Methods:</h3> Patients with RA participating in the Bari ph3 long-term extension study who received Bari 4-mg for ≥15 months and who achieved sustained low disease activity ([LDA] – CDAI score ≤10) or remission ([REM] – CDAI ≤2.8) ≥3 months apart were re-randomised in a blinded manner to continue Bari 4-mg or step down to 2-mg. Patients could rescue to Bari 4-mg. Efficacy and safety were assessed through 48 weeks (wks) following re-randomisation. <h3>Results:</h3> The majority of patients in both groups maintained the state of LDA or REM over the 48 wks. However, dose reduction to 2-mg resulted in significant increases in disease activity at 12, 24, and 48 wks (Table). Dose reduction also resulted in a shorter time to relapse (defined as loss of step-down eligibility criteria); significantly more patients relapsed over 48 wks compared to the 4-mg group (figure 1). Rescue rates were 8.3% for Bari 4-mg, 16.6% for Bari 2-mg. Most rescued patients could regain LDA or REM. Dose reduction was associated with a lower rate of infections; rates of SAEs and AEs leading to discontinuation were similar across groups. <h3>Conclusions:</h3> These data indicate that disease control was better maintained with Bari 4-mg than 2-mg. However, most stepped-down patients could maintain LDA or REM, or recapture control with re-introduction of the 4-mg dose. Stepping down to a dose of 2-mg daily may be a viable option for many patients who have achieved sustained LDA or REM on the 4-mg dose. <h3>Disclosure of Interest:</h3> T. Takeuchi Consultant for: Pfizer Japan Inc., Astra Zeneca K.K., Eli Lilly Japan K.K., Novartis Pharma K.K., Daiichi Sankyo Co.,Ltd., Nipponkayaku Co.Ltd, Janssen Pharmaceutical K.K., Merck Serono Co.,Ltd., Takeda Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Astellas Pharma Inc, AbbVie GK, Bristol–Myers K.K. Asahi Kasei Medical K.K, Speakers bureau: Celtrion, Nipponkayaku Co.Ltd, Pfizer Japan Inc.,UCB Japan., Diaichi Sankyo Co.,Ltd., Takeda Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co,. Ltd., AbbVie GK., Bristol–Myers K.K., Eisai Co., Ltd., Mitsubishi Tanabe Pharma Co., Janssen Pharmaceutical K.K., and Astellas Pharma Inc, M. Genovese Grant/research support from: Eli Lilly &amp; Company, AbbVie, Consultant for: Eli Lilly &amp; Company, AbbVie, B. Haraoui Grant/research support from: Abbvie, Pfizer, Consultant for: Abbvie, Amgen, Eli Lilly and Company, Merck, Pfizer, UCB, Speakers bureau: Pfizer, UCB, Z. Li: None declared, L. Xie Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, R. Klar Employee of: IQVIA, A. P. Correia Employee of: Eli Lilly and Company, S. Otawa Employee of: Eli Lilly and Company, P. Lopez-Romero Employee of: Eli Lilly and Company, I. De La Torre Employee of: Eli Lilly and Company, T. Rooney Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, J. Smolen Grant/research support from: AbbVie, Janssen, Eli Lilly and Company, MSD, Pfizer, Roche, Consultant for: AbbVie, Amgen, Astra-Zeneca, Astro, BMS, Celgene, Celltrion, Chugai, Gilead Glaxo, ILTOO, Janssen, Eli Lilly and Company, Medimmune, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi-Aventis, UCB